MAUDE MDR 9857971
- MDR report key
- 9857971
- Report number
- 3007738819-2019-00003
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. JIRO HIRAI
- Address
- 1-50-1 SASAZUKA,SHIBUYA-KU TOKYO, 151-0 JA
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OSFERION | FILLER, BONE VOID, CALCIUM COMPOUND | OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY | MQV | 60A3 | M18401C357 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-19 | 0 | 1. H; 2. R |
Event Narratives#
No narrative records found.